InspireMD, Inc. (NASDAQ:NSPR) ("InspireMD," or the "Company"), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced that, in consultation with the U.S. Food and Drug Administration ("FDA"), the Company has initiated a voluntary recall in the U.S. for its CGuard® Prime 135 cm carotid stent delivery system.

The Company acted after determining during a controlled launch that the technical success of the delivery system during carotid artery stenting ("CAS") procedures has not met performance expectations. This action is voluntary with no implications for the safety of patients who have previously received the CGuard stent.